- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07714681
Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
14 juli 2026 uppdaterad av: Chou Kee Lee, Education University of Hong Kong
- To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
- To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
- To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
195
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- family dementia caregivers aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have moderate to high stress
Exclusion Criteria:
- Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Grupp 2
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In the second phase, the receptivity of the brief mindfulness intervention will be examined within a just-in-time adaptive intervention (JITAI) framework, comprising distal outcomes, a proximal outcome (engagement with the brief intervention), decision points, intervention options (which notification-delivery model is applied), a tailoring variable (predicted receptivity), and decision rules.
In the first four days, as in the first phase, participants will be interviewed with a structured questionnaire and will receive a four-day psycho-education intervention.
Over the subsequent 14-day micro-randomized trial (Day 5 to Day 18), notification-delivery models will be randomized at scheduled daily decision points.
From Day 5 to Day 11, prompts will be delivered by either a random or a static machine-learning model with equal probability; from Day 12 to Day 18, prompts will be delivered by a random, static, or adaptive machine-learning model with equal probability, with the adaptive model u
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Experimentell: Grupp 1
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In the first phase of the study, participants will be interviewed by a research assistant over the phone with a structured questionnaire on the first day of the study period.
They will then receive a four-day psycho-education intervention, during which the study application will be installed on their smartphone.
At the end of the fourth day, participants will be asked to use the app for the following 16 days of the micro-randomized trial (MRT).
In the 16-day MRT (Day 5 to Day 20), zero to six ecological momentary assessments (EMAs), separated by at least 30 minutes, will be delivered each day (from one hour after self-reported wake time to one hour before self-reported sleep time) to classify whether the participant is probably-stressed or probably-not-stressed using a single stress item.
Immediately following each EMA, participants will be randomized to receive a brief mindfulness intervention prompt or no prompt, with randomization occurring only if no brief mindfulness intervention
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Perceived Stress
Tidsram: baseline and immediately after intervention
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14-item perceived stress scale.
Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.
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baseline and immediately after intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Depressive Symptoms
Tidsram: baseline and immediately after intervention
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Patient health questionnaire 9, items are rated on a 4-point scale, ranging from 0 to 27, with higher scores reflecting greater depression severity.
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baseline and immediately after intervention
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caregiving burden
Tidsram: baseline and immediately after intervention
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12-item Zarit Burden Interview, items are rated on a 5-point scale, ranging from 0-48, with higher scores denoting greater burden.
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baseline and immediately after intervention
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Positive Aspect of Caregiving
Tidsram: baseline and immediately after intervention
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Positive Aspects of Caregiving Scale, items are rated on a 5-point Likert scale, ranging from 9-45, with higher scores indicating a more positive appraisal
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baseline and immediately after intervention
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sleep quality
Tidsram: baseline and immediately after intervention
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Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.
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baseline and immediately after intervention
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quality of life
Tidsram: baseline and immediately after intervention
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EuroQoL 5-Dimension 5-Level measures across 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), score ranging from 0-100, higher scores reflect better health-related quality of life.
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baseline and immediately after intervention
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Mindfulness
Tidsram: baseline and immediately after intervention
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15-item Mindful Attention Awareness Scale, items are rated on a 6-point scale, score ranging from 1-6, with higher scores indicating greater dispositional mindfulness.
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baseline and immediately after intervention
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Prompt-Specific Questions
Tidsram: during and immediately after intervention
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app backend records of post-prompt engagement with the brief intervention, including just-in-time response (engagement within the just-in-time window) and response delay; and single-item ecological momentary assessment ratings of stress, positive mood, and negative mood administered immediately following each completed intervention
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during and immediately after intervention
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feasibility and acceptability rate of the app
Tidsram: immediately after intervention
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immediately after intervention
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mindfulness intervention specific questions
Tidsram: immediately after intervention
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immediately after intervention
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Kee Lee Chou, PhD, The Education University of Hong Kong
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 november 2024
Primärt slutförande (Faktisk)
31 december 2025
Avslutad studie (Faktisk)
31 december 2025
Studieregistreringsdatum
Först inskickad
8 juli 2026
Först inskickad som uppfyllde QC-kriterierna
14 juli 2026
Första postat (Faktisk)
20 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2021-2022-0276
- 20210051 (Annat bidrag/finansieringsnummer: Health and Medical Research Fund)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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